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The ZEISS YELLOW 560 is a surgical microscope accessory used in viewing and visual assessment of intraoperative blood flow in the cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels.

It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery.

The YELLOW 560 Fluorescence Module is an accessory to the ZEISS surgical microscope OPMI PENTERO 800 and OPMI PENTERO 900 for visualizing blood flow intraoperatively. The YELLOW 560 Fluorescence Module integrated into the OPMI PENTERO 800 / OPMI PENTERO 900 surgical microscope allows the surgical microscope to produce filtered light to illuminate the fluorescence properties of the sodium fluorescein dye and to detect the emitted fluorescent signal to examine the human vascular system during surgery. This is achieved by placing a filter in the illumination path and a second filter in the optical (viewing) path.

The filters of the YELLOW 560 Fluorescence Module are optimized to deliver excitation wavelengths ranging from 460 to 500 nm and to emphasize fluorescence signals in wavelengths ranging from 540 to 690 nm that typically correspond to the excitation and emission spectrum of sodium fluorescein. The option to place the filters for YELLOW 560 is controlled via either the handgrip of the surgical microscope or the foot control.

Sodium fluorescein may be used as a fluorescence contrast agent to examine arteriovenous malformations (AVM), aneurysms, and vessel anastomoses. The dye helps to visualize intraoperative blood flow and vessel patency. Sodium fluorescein can be used as contrast agent with YELLOW 560 without changes to the formulation, mode of action, approved dose or route of administration.

The provided text describes the Carl Zeiss Meditec AG YELLOW 560 Fluorescence Module, an accessory for surgical microscopes designed for intraoperative visualization of blood flow. However, it does not include detailed acceptance criteria or a specific study demonstrating that the device meets those criteria. Instead, it relies heavily on substantial equivalence to predicate devices and general statements about verification and validation testing, and a literature review.

Therefore, many of the requested sections below cannot be fully populated from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the YELLOW 560 Fluorescence Module. It states that internal verification testing was conducted to verify the optical performance and system performance, and that "the YELLOW 560 Fluorescence Module met all the requirements." However, these requirements themselves are not detailed.

The "performance" is primarily described in terms of its intended use and comparison to predicate devices, rather than quantifiable metrics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of an algorithm or AI. The validation activities mentioned are more related to system functionalities and usability for the medical device itself.

Clinical validation is supported by a review of clinical literature, rather than a new, dedicated clinical study with a defined sample size for the YELLOW 560 device alone. The literature cited discusses the use of YELLOW 560 and sodium fluorescein angiography in cerebrovascular surgery.

• Sample Size: Not specified for a dedicated test set. The clinical evidence is based on "various researchers" and studies reported in "the clinical literature."
• Data Provenance: Clinical literature review. Implicitly, this would be prospective clinical data collected by the original researchers of the peer-reviewed articles. The countries of origin are not specified, though the manufacturer is German.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. Since the clinical evidence relies on a literature review rather than a new study with a "test set" and ground truth establishment, the document doesn't detail experts involved in establishing ground truth for a specifically defined test set for this submission. The "ground truth" in the reviewed clinical literature would have been established by the surgeons and medical professionals performing the procedures and assessments in those studies.

• Number of Experts: Not specified for this submission's clinical evaluation.
• Qualifications of Experts: Not specified.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided. As there's no defined "test set" in the context of an AI/algorithm evaluation with specific ground truth adjudication, this is not applicable in the way it's typically requested for AI devices. The clinical literature review would rely on the methodologies of the original publications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

An MRMC study was not conducted for this submission comparing human readers with and without AI assistance. The device is a fluorescence module for a surgical microscope, aiding human visualization, not an AI algorithm that independently interprets data or assists human readers in a diagnostic setting in the typical MRMC sense.

However, the clinical evaluation section does mention a publication that provides a comparison of the YELLOW 560 Fluorescence Module (with sodium fluorescein) and the predicate device INFRARED 800 with FLOW 800 option (with Indocyanine Green - ICG) in aneurysm surgery in the same patients. This is a comparative study of two different visualization technologies, not an MRMC study related to AI assistance.

• Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as this is not an AI-assisted diagnostic device in that context. The device itself is the enhancement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The YELLOW 560 Fluorescence Module is a hardware accessory to a surgical microscope. Its function is to facilitate the surgeon's (human-in-the-loop) visualization of blood flow. It is not an algorithm that operates standalone.

7. The Type of Ground Truth Used

For the clinical evaluation, the "ground truth" is implied to be the intraoperative visual assessment and clinical outcomes as reported in the peer-reviewed clinical literature by practicing surgeons. This includes:

• Effective real-time visualization of blood flow.
• Visual assessment of vessel types in AVM surgery.
• Assessment of cerebral aneurysms, vessel branch occlusion, and patency of very small perforating vessels.

This is essentially expert consensus/clinical judgment/outcomes data from the studies reviewed.

8. The Sample Size for the Training Set

This information is not applicable. The YELLOW 560 Fluorescence Module is a passive optical accessory to a surgical microscope; it is not an AI/machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for this device.

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